Remote Manufacturing Operations Manager Jobs

Position Summary:

The Vice President, Manufacturing Operations will report to the SVP Product Development and Manufacturing (PD&T) and will be responsible for leading the transition from a clinical-stage organization to an effective commercial manufacturing organization. As a key partner to the SVP PD&T, the candidate will lead and develop a best-in-class manufacturing and supply chain team that can collaboratively work across functions to enable commercial launch of our lead product into global markets. While working with internal teams, such as quality, regulatory, commercial, and finance, and external contract service providers, the individual is responsible for ensuring that the end-to-end supply chain is set up to meet the global commercial product demand with keen eye towards continuous process improvement.

Responsibilities:

• Leads the manufacturing and supply chain teams, providing leadership aligned with Vera values resulting in a high performing organization
• Contributes to the strategic leadership of Vera’s late-stage programs acting as a strong team player
• Participate in sales and operations planning (S&OP) and Product Development Teams representing the Product Development and Manufacturing function
• Create synergy and knowledge sharing to enable optimal production planning processes to balance supply/demand risks
• Serves as a single point of contact to manage end-to-end global supply chain and foster the needed supplier relationships to drive excellence using appropriate metrics
• Serves as a strategic thought leader to craft and manage commercial supply contracts with an eye towards life cycle extension programs
• Create, develop and manage necessary tools for end-to-end demand/supply planning
• Provide strategic direction, technical guidance, and long-range planning for late-stage programs: BLA-enabling studies through BLA submission, commercial launch, and sustaining operations
• Develop and manage department budgets and ensure fiscal responsibility for manufacturing operations
• Develop fit for purpose operational processes and systems to support supplier metrics and other tools to enable continuous improvement / process excellence
• Willingness to take on additional duties and responsibilities as assigned, and to adapt to changes in job scope as organizational needs evolve

Qualifications:

• Master's degree required. PhD preferred. Degree in Life Sciences or Engineering preferred
• 15+ years of relevant experience from biopharmaceutical manufacturing required.
• 5+ years of senior-level line management experience leading other leaders required
• Proven track record of creating business results
• Deep technical, operational, regulatory, strategic, and quality expertise, along with a proven track record of leading late-stage programs in innovative biotech or pharmaceutical organizations
• Experience with operating and navigating regulatory requirements including authoring and reviewing BLAs and interacting with regulatory authorities
• Solid understanding of drug development within the biopharmaceutical industry
• Experience within development and manufacturing of monoclonal antibodies or related field preferred
• Excellent interpersonal skills, collaborative leadership style
• Leads by example in recognizing and modeling Vera values
• Learning agility: ability to seek input, make connections, recognize patterns that lead to effective decision-making and action
• Proven ability to thoughtfully evaluate processes, identify opportunities for improvement and successfully execute on those plans
• Strong communication skills (oral & written); able to effectively interact with all levels internally and externally – able to tailor communications to the audience to achieve desired results
• Attention to detail with ability to move easily between hands-on work and strategic thinking
• Ability to multitask and prioritize.
• Strong leadership skills with a desire to nurture, train, and grow the existing finance group
• Demonstrated ability to influence and deliver results in a virtual (outsourced) environment

At Vera, base pay is only one part of your total compensation package. The successful candidate will be eligible for an annual performance incentive bonus, new hire equity, and ongoing performance-based equity. Vera Therapeutics also offers various benefits offerings, including, but not limited to, medical, dental, and vision insurance, 401k match, flexible time off, and a number of paid holidays.

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